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TPLC
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Device
mattress, air flotation, alternating pressure
Regulation Description
Alternating pressure air flotation mattress.
Product Code
FNM
Regulation Number
880.5550
Device Class
2
MDR Year
MDR Reports
MDR Events
2020
58
58
2021
47
47
2022
75
75
2023
197
197
2024
254
254
2025
7
7
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
87
87
Insufficient Information
80
80
Deflation Problem
59
59
Increase in Pressure
36
36
Sparking
32
32
Dent in Material
23
23
Use of Device Problem
20
20
Appropriate Term/Code Not Available
19
19
Inflation Problem
15
15
Unintended Deflation
13
13
Electrical Shorting
11
11
No Apparent Adverse Event
11
11
Patient-Device Incompatibility
11
11
Electrical /Electronic Property Problem
10
10
Unintended Electrical Shock
9
9
Melted
8
8
Infusion or Flow Problem
8
8
Smoking
7
7
Pressure Problem
6
6
Detachment of Device or Device Component
6
6
Fire
6
6
Malposition of Device
4
4
Patient Device Interaction Problem
4
4
Mechanical Problem
4
4
Difficult or Delayed Positioning
4
4
Device Slipped
4
4
Product Quality Problem
3
3
Gas/Air Leak
3
3
Defective Component
3
3
Protective Measures Problem
3
3
Disconnection
2
2
Device-Device Incompatibility
2
2
Therapeutic or Diagnostic Output Failure
2
2
Material Too Rigid or Stiff
2
2
Thermal Decomposition of Device
2
2
No Pressure
2
2
Material Split, Cut or Torn
2
2
Installation-Related Problem
2
2
Contamination /Decontamination Problem
2
2
Inadequacy of Device Shape and/or Size
2
2
Circuit Failure
2
2
Decrease in Pressure
2
2
Complete Loss of Power
2
2
Sharp Edges
2
2
Self-Activation or Keying
2
2
Inadequate or Insufficient Training
1
1
Decreased Pump Speed
1
1
Power Problem
1
1
Loose or Intermittent Connection
1
1
Failure to Power Up
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
228
228
Fall
154
154
Pressure Sores
100
100
Insufficient Information
34
34
Tissue Breakdown
33
33
Ulcer
16
16
Skin Tears
15
15
Pain
14
14
No Consequences Or Impact To Patient
11
11
Electric Shock
11
11
Bruise/Contusion
8
8
Head Injury
7
7
Bone Fracture(s)
7
7
Laceration(s)
6
6
Physical Entrapment
5
5
Localized Skin Lesion
5
5
Skin Erosion
4
4
Pleural Effusion
4
4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
4
4
Abrasion
4
4
Joint Dislocation
4
4
Burn(s)
3
3
Hematoma
3
3
Blister
3
3
Vertebral Fracture
2
2
Skin Infection
2
2
Swelling/ Edema
2
2
No Patient Involvement
2
2
Fungal Infection
2
2
Skin Discoloration
2
2
Injury
2
2
Skull Fracture
2
2
Contusion
1
1
Acoustic Shock
1
1
Fatigue
1
1
No Known Impact Or Consequence To Patient
1
1
Headache
1
1
Unspecified Infection
1
1
Limb Fracture
1
1
Multiple Fractures
1
1
Superficial (First Degree) Burn
1
1
Skin Inflammation/ Irritation
1
1
Contact Dermatitis
1
1
Unspecified Tissue Injury
1
1
Neck Pain
1
1
Impaired Healing
1
1
Hip Fracture
1
1
Pneumonia
1
1
Swelling
1
1
Discomfort
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Getinge (Suzhou) Co Ltd
II
Jun-04-2021
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